Using folinic acid to reduce toxicity from pemetrexed in cancer treatment
The Effect of Oral Folinic Acid Rescue Therapy on Pemetrexed Induced Neutropenia: A Randomized Open-label Trial
This study is testing if giving folinic acid can help reduce side effects from a cancer drug called pemetrexed for people with advanced lung cancer or mesothelioma.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Amphia Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 2 sites (Breda, Noord Brabant and 1 other locations) |
| Trial ID | NCT06010277 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the hematological toxicity experienced by patients undergoing treatment with pemetrexed, comparing those who receive folinic acid as a rescue therapy to those who do not. The primary endpoint focuses on the difference in neutrophil counts between the two groups at days 8-10 post-administration of pemetrexed. Secondary endpoints include assessing the severity of neutropenia, plasma homocysteine levels, chemotherapy efficacy, and the incidence of treatment interruptions. The trial involves 50 patients with stage IV non-small cell lung cancer or mesothelioma, participating in a multi-center, open-label, randomized design over four treatment cycles.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with stage IV non-small cell lung cancer or mesothelioma who are eligible for pemetrexed-based chemotherapy.
Not a fit: Patients with contraindications to folinic acid or those with anemia due to vitamin B12 deficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of hematological toxicity in patients receiving pemetrexed, improving their overall treatment experience.
How similar studies have performed: While this approach is not widely tested, similar studies have shown promise in managing chemotherapy-induced toxicity with supportive therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. ≥18 years old 2. Eligible for treatment with pemetrexed-based chemotherapy based on indication. 3. ECOG performance score of 0-2. 4. Subject is able and willing to sign the Informed Consent Form A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Contraindications for treatment with folinic acid in line with the SmPC. 1. Hypersensitivity to the active substance or to any of the excipients. 2. Anaemia caused by vitamin B12 deficiency. 2. The presence of clinically relevant drug-drug interactions, according to the current SmPC of folinic acid.
Where this trial is running
Breda, Noord Brabant and 1 other locations
- Amphia Hospital — Breda, Noord Brabant, Netherlands (Recruiting)
- Albert Schweitzer Hospital — Dordrecht, Zuid Holland, Netherlands (Not_yet_recruiting)
Study contacts
- Study coordinator: Ramon Contrucci, MSc
- Email: rcontrucci@amphia.nl
- Phone: 0765954354
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.